Nucleic Acids Technologies for Diagnostics
Event Information
Document Title
Agenda
| Day One Tuesday, May 20, 2008 | DAY ONE | DAY TWO | | ||||
| Regulatory Pathways and Quality Strategies | ||||
| 7:30 | Networking Coffee | |||
| 7:45 | Chairperson's Opening Remarks B. Melina Cimler, Ph.D., Senior Vice President, Quality and Regulatory Affairs, Beckman-Coulter Inc. | |||
| Keynote Presentations | ||||
| 8:00 | Nucleic Acid Technologies for Diagnostics - FDA Perspectives on Why the Tortoise Won the Race FDA has been regulating diagnostics since implementation of the Medical Device Amendments of 1976. Regulation is science based and involves an overlapping series of well defined but flexible premarket and postmarket controls. By promoting sound science, FDA believes it adds value to marketed products and ensures that transition to new diagnostic frontiers occurs in a safe and effective manner that both protects and promotes public health. Steven I. Gutman, M.D., Director, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH, U.S. Food and Drug Administration | |||
| 8:30 | Increasing International Challenges in Regulatory and Compliance for Diagnostic Products The EU had been quite successful to harmonize the regulations within their member states into basically one common regulatory framework for In Vitro Diagnostic Medical Devices. Meanwhile the regulations have been multiplied and spread into other areas, like Latin America or Asia/ Pacific. Manufacturers are challenged by the diverse requirements and burdensome administration for worldwide product registrations. The presentation will highlight some of the major challenges and will give an outlook into the future. Petra Kaars-Wiele, Ph.D., Senior Director, International Regulatory Affairs and Affiliate Compliance, Diagnostic Division, Abbott Laboratories, Germany | |||
| 9:00 | GeneSearch™ Breast Lymph Node (BLN) Assay - IVD PMA Process for New Indications/Molecular Diagnostic from Day 100 to Approval On July 16th, 2007, Veridex received FDA PMA approval for the GeneSearch™ Breast Lymph Node (BLN) Assay. The GeneSearch™ BLN Assay is a real-time reverse transcriptase polymerase chain reaction (RT-PCR) diagnostic test that detects the presence of breast tumor cell metastasis in lymph nodes. This BLN Assay Case study will review experiences and "lessons learned" from the FDA Advisory Panel Meeting, receiving a FDA Approvable Letter, and Sponsor discussions with OSB/OIVD on Post Approval Study commitments. Debra J. Rasmussen, RAC, MBA, Worldwide Executive Director, Regulatory Affairs, Veridex, LLC | |||
| 9:30 | A Regulatory Strategy for Emerging Molecular Diagnostics Recent advancements in genomic and molecular sciences hold great future promise for improving public health (e.g. personalized medicine). Novel technologies present great challenges for the current FDA premarket review paradigm where they compete with older, well-standardized tests for scarce review resources. The discussion will present principles and an approach for least burdensome regulation of new and established IVDs and laboratory developed tests. Michele M. Schoonmaker, Ph.D., Director, Government Affairs, Cepheid | |||
| 10:00 | Networking Poster and Exhibit Viewing Refreshment Break | |||
| 10:45 | Regulatory Development Issues: Companion Diagnostics and Therapeutics We are in an active era of targeted molecular therapy and understanding the role molecular assays will play in predicting sensitivity or resistance to these drugs. Selecting patients most likely to benefit from these agents has given rise to expanding interest in development of new companion diagnostics. Challenges and practical consideration in the co-development of drugs and diagnostics from a diagnostic regulatory perspective will be discussed. William J. Pignato, Senior Scientist, Regulatory Affairs, Genentech, Inc. | |||
| 11:15 | The Regulation of Molecular Diagnostics: An Overview of Global Trends Update your knowledge of evolving regulatory structures which govern molecular diagnostics in the United States, Canada, Europe and Australia. Compare national/regional approaches to issues such as risk classification, the regulation of laboratory developed tests and the role of third parties in device review. Special consideration will be given to the regulation of pharmacogenetic tests and the role of international bodies such as the Global Harmonisation Task Force. Stuart Hogarth, Research Associate, Social Sciences, Loughborough University, United Kingdom | |||
| Audience Interactive Panel Discussion | ||||
| 11:45 | Regulatory Pathways and Quality Strategies Moderator: B. Melina Cimler, Ph.D., Senior Vice President, Quality and Regulatory Affairs, Beckman-Coulter Inc. Panelists: Steven I. Gutman, M.D., Director, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH, U.S. Food and Drug Administration Petra Kaars-Wiele, Ph.D., Senior Director, International Regulatory Affairs and Affiliate Compliance, Diagnostic Division, Abbott Laboratories, Germany William J. Pignato, Senior Scientist, Regulatory Affairs, Genentech, Inc. Michele M. Schoonmaker, Ph.D., Director, Government Affairs, Cepheid Stuart Hogarth, Research Associate, Social Sciences, Loughborough University, United Kingdom Peter Haima, Ph.D., Senior Project Manager In Vitro Diagnostics, Eurogentec S.A., Belgium | |||
| 12:15 | Lunch and Roundtable Discussion in Poster and Exhibit Hall | |||
| 12:30 - 1:30 | Roundtable Discussions IVD Diagnostics: Regulatory Challenges and Prospects Chemical Modifications that Reduce Off-Target Effects of siRNAs Peptide Drug Delivery Systems Oligo Drug Delivery Systems | |||
| Analytical Methods and Validation | ||||
| 1:45 | Chairperson's Remarks Timothy Stenzel, M.D., Ph.D., Vice President, Diagnostics R&D and Chief Medical Officer, Asuragen, Inc., A Spin-Off of Ambion | |||
| 2:00 | Quality Management in the Manufacturing of Primers and Probes for Molecular Diagnostics Assays Oligonucleotides are critical components of molecular diagnostic assays. Consistent functional performance is only assured with a GMP manufacturing process, requiring compliance with FDA 21CFR820 and ISO13485. IVD kits contain GMP oligos, whereas Lab Developed Tests often contain non-GMP oligos. Both approaches will be discussed in light of the Eurogentec GMP manufacturing process from a financial, quality, risk management and regulatory perspective. Peter Haima, Ph.D., Senior Project Manager In Vitro Diagnostics, Eurogentec S.A., Belgium | |||
| 2:30 | The Development and Validation of Companion Diagnostics—Importance of the Clinical Laboratory The appropriate development of companion diagnostics (CDx) is critical to the future of the pharmaceutical industry. It is becoming increasingly clear that the clinical laboratory industry will be taking on greater responsibility for the success of CDx. The value of true collaborative efforts between the pharmaceutical industry, device manufacturers and clinical laboratories will be the focus of this presentation. Glenn A. Miller, Ph.D., Vice President, General Manager, Genzyme Analytical Services | |||
| 3:00 | Challenges in the Validation of Test Methods Used for Oligo Manufacturing A number of test methods are used during the manufacture of oligonucleotides including gel filtration chromatography, reverse phase chromatography, anion exchange chromatography, UV/VIS/FL spectroscopy and reporter over quencher fluorescence. These methods are applied to large number of oligonucleotides which make the method validation challenging. This challenge can be handled efficiently by grouping the oligonucleotides into families for the purpose of method validation. Michael D. Geier Ph.D., Director, Analytical Development and Test Method Validation, Roche Molecular Diagnostics | |||
| 3:30 | Networking Poster and Exhibit Viewing with Refreshments | |||
| 4:00 | IVD, ASR, RUO and Assay Validation: The Alphabet Soup of the Clinical Diagnostics Laboratory The presentation will discuss the regulations imposed upon the clinical diagnostic laboratory for the use of diagnostic assays with different regulatory designations. The ASR validation process will be specifically addressed. Diagnostic product manufactures with a keen knowledge of these regulations will better be able to position their products to be successful in a competitive market. Brian DuChateau, Ph.D., Vice President, Laboratory Operations, Converge Diagnostic Services | |||
| 4:30 | A New Concept for Standardization of NAT Assays across Different Platforms, Laboratories and Technologies "A fundamental goal of laboratory medicine is that results for patients' samples will be comparable independent of the medical laboratory that produced the results." (W. Greg Miller et al. Clinical Chemistry 2006;52:553-554). A strategy for achieving this goal for NAT assays using metrologically traceable and commutable control materials will be presented. E. Ralf Schönbrunner, Ph.D., Vice President, Research and Development, AcroMetrix | |||
| Featured Future Directions Presentation | ||||
| 5:00 |
Preventive therapy with statins results in a substantial reduction of primary and secondary coronary events. Despite the overall cholesterol lowering benefits of statins, a fraction of patients on statin therapy appear to receive little or no survival benefit from the treatment. The results for a common biomarker for both risk of coronary heart disease and statin response will be presented. Andrew Grupe, Ph.D., Senior Director, Pharmacogenomics and Director, CNS Research, Celera | |||
| 5:30 | Networking Reception in Poster and Exhibit Hall Dedicated Poster Viewing: Poster presenters are requested to be present at their posters. | |||
| Day Two Wednesday, May 21, 2008 | DAY ONE | DAY TWO | | ||||
| New Technologies: Planning for Tomorrow's Diagnostics | ||||
| 7:45 | Networking Coffee | |||
| 8:00 | Chairperson's Remarks Marc Lemaitre, Ph.D., Director, R&D, Glen Research Corp. | |||
| Keynote Presentation | ||||
| 8:15 | Unnatural Base Pair Systems for DNA/RNA-Based Biotechnology The creation of unnatural base pairs, compatible with the natural A-T(U) and G-C base pairs, could expand the genetic alphabet for the site-specific incorporation of extra, functional components into nucleic acids and proteins. We have developed a series of unnatural base pairs, which exhibit unique specificity in in vitro replication, transcription or translation. This unnatural base pair system system may provide a variety of biotechnology applications. Ichiro Hirao, Ph.D., Team Leader, Nucleic Acid Synthetic Biology Research Team, RIKEN Genomic Sciences Center (GSC); President, TagCyx Biotechnologies, Japan | |||
| 9:00 | Molecular Imaging with Oligonucleotides Molecular Imaging can assess gene expression non-invasively, repeatedly and quantitatively in living subjects. Pharmaco-Imaging of oligonucleotides allows quantifying in 3-D and in the whole body of animals and humans the bio-distribution time course of antisense, aptamers, interfering RNAs, ribozymes, etc. Use of oligonucleotides as contrast agents requires that a sufficient contrast is obtained and that the correlation between tracer and target concentrations is demonstrated. Bertrand Tavitian, M.D., Ph.D., Head of the Laboratoire d'Imagerie Moleculaire Experimentale, Institute for Biomedical Imaging, CEA, France | |||
| 9:30 | Designing Multiplex STR Genotyping Assays for Human Identification Using our non-nucleotide linkers and 5-dye fluorescent technology we have developed highly discriminating multiplex short tandem repeat (STR) assays for human identification. In this presentation, we will present some of the challenges we encountered and the solutions we implemented when developing these multiplexed STR assays to meet the needs of the forensic community. Lori K. Hennessy, Ph.D., Director, R&D, Human Identification Group, Applied Markets Division, Applied Biosystems | |||
| 10:00 | Poster and Exhibit Viewing Refreshment Break | |||
| 10:45 | Ferrocene DNA Oligonucleotides and Electrochemical Microarrays Phosphoramidites containing ferrocenes with discrete electrode potentials are used to synthesize short DNA oligonucleotides. These structures present analytical, synthetic and purification challenges for which we have developed processes used in downstream manufacturing. Using electrode surface capture and electrochemical detection of amplicon:ferrocene-oligonucleotide hybrids we have developed low to medium density multiplex arrays useful for mutation characterization of the Cystic Fibrosis CFTR gene and Warfarin metabolism. Dick Keys, Ph.D., Senior Director, Chemistry and Product Development, Osmetech Molecular Diagnostics | |||
| 11:15 | MicroRNA: Emerging Biomarkers and Advances in Molecular Diagnostics A deepening understanding of miRNA biology underscores the importance of expression alterations in these small RNAs that are now associated with many diseases, including cancer. As a result, miRNAs are increasingly promising biomarkers for both diagnostic and therapeutic applications. In this presentation, we will describe how technology innovations have illuminated clinical opportunities for miRNA. Gary J. Latham, Ph.D., Head of Technology Development, Asuragen, Inc. | |||
| 11:45 | High Throughput microRNA Expression Profiling Using a Bead Based Multiplex System Recent publications have shown that cancers have specific miRNA profiles that either classify the cancer, or give prognostic information. A bead based multiplexed assay was developed to address both specificity needs and throughput needs for an assay to profile miRNA in tissues. The profiles of various cancers will be shown and discussed. David E. Smith, Ph.D., Associate Director, Scientific Awareness, Luminex Corporation | |||
| 12:15 | Lunch in Poster and Exhibit Hall | |||
| New Technologies Session Continued | ||||
| 1:45 | IsoAmp® Molecular Analyzer, a Disposable Molecular Diagnostic Device for Point-of-Care Pathogen Detection BioHelix has developed the IsoAmp® Molecular Analyzer, a simplified diagnostic platform for nucleic acid testing without specialized instrumentation. The platform consists of manual sample prep, isothermal Helicase-Dependent Amplification; and detection with the BEST™ Cassette. IsoAmp® tests achieve single-copy sensitivity and use target probes and internal controls to ensure specificity. Assays under development include Clostridium difficile, Staphyloccus aureus, and Methicillin-resistant Staphylococcus aureus. Tamara Ranalli, Ph.D., Manager, Business Development and Quality Systems, BioHelix Corporation | |||
| 2:15 | Targeted Resequencing of Enriched Genomic Regions: Maximizing the Efficiency of Next-Generation Sequencing Platforms Jeremy Lambert, Program Manager, RainDance Technologies, Inc. | |||
| Business Considerations for Successful Launch in Clinical Market | ||||
| 2:45 | Chairperson’s Remarks Loren "Dick" Keys, Ph.D., Senior Director, Chemistry and Product Development, Osmetech Molecular Diagnostics, Inc. | |||
| 3:00 | Nanotechology Medical Device Development and Product Launch Nanosphere's Verigene® System is a bench top molecular diagnostics workstation uniquely suited to meet present-day needs and drive the future potential of the biomarker-driven field of diagnostics. The development of the Verigene system was a multidisciplinary technology development and integration effort. The Verigene System® is the first nanotechnology based clinical diagnostic platform in the world with FDA Clearance. William Cork, Chief Technology Officer and V.P. Research & Development, Nanosphere, Inc. | |||
| 3:30 | Networking Refreshment Break | |||
| 4:00 | Latest Legal and Licensing Developments in Relation to PCR We will discuss the latest legal and licensing developments of PCR. There will be an update of the enzyme Patents, including a discussion of a variety of thermostable enzymes and their impact on licensing opportunities. With the expiration of the foundational PCR patents, the implications for Hot Start, Real-Time PCR,qPCR, RT-PCR, etc., will be discussed with an emphasis on alternative strategies. James R. Troupis, Lead Trial Counsel for Promega Corporation, Michael Best & Friedrich LLP | |||
| 4:30 | Qualifying Manufacturing Material Suppliers for Molecular Diagnostics and Therapeutics The responsibility of ensuring that raw materials used in the manufacture of molecular diagnostics and therapeutics is ultimately the responsibility of the finished product manufacturer. Manufacturers must define, communicate, and enforce the quality expectations that they have for their raw material suppliers. This presentation explores the challenges and methods of identifying, qualifying, and managing raw material suppliers in this growing industry. Jim Darnell, Manager, Life Sciences, Clarkson Consulting | |||
| 5:00 | Close of Nucleic Acids Technologies for Diagnostics Conference | |||
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